SPC Seminar -- a brief report

The SPC Blog's first SPC seminar got off to a great start yesterday with over 70 SPC aficionados together in the same room for a whole afternoon to listen to SPC perspectives on patent extension law and practice France, Germany and the UK -- and to try to quench their thirst on burning SPC issues.

SPC Blog team member (and seminar chairman) Robert Stephen kicked off the event by providing his view on the current issues in the field.

Rob was then followed by Michèle Lavé (left), from the French patent attorney firm Cabinet Alice de Pastors.  Michèle discussed SPCs in France including SPCs the patent requirements for combination products (Ritonavir, lanzoprazole and emtricitabine combinations), marketing authorization requirements (Flufenacet combination case), definition of the term product (French Timolol and Carmustine decisions) as well as the French position with regard to negative term SPCs.

Matthias Kindler and Niels Hölder of Hoffmann-Eitle (Munich) then took a look at German SPC cases in 2008: they delved into the seemingly unending topic of determining what a first authorization is, especially when the first authorization is one in an EEA member state (the EEA was founded after Regulation 1768/92 entered into force, and the Regulation came into force before, SE, FI and AT acceeded to the EC). This issue was decided by the German Federal Supreme Court (FSC) in the "Pantoprazol" case (X ZB 31/06, 27 May 2008). They also tackled the combination issue ("Anti-helicobacter preparation", FSC X ZB1/08, 8 July 2008) and the problem of having different salts as different active ingredients (FSC X ZB 4/08, 14 October 2008). They then reported on the decision of the German Patent Court to refuse the grant of an SPC with a negative term. This decision has been appealed.

Lawrence Cullen of the Intellectual Property Office addressed SPCs for combinations and the relevant UK case law (Takeda and Gilead). He also spent some time discussing the SPC extension and the Paediatric Regulation as well as the the granting of negative term SPCs. Finally he briefly presented current ECJ references.

The afternoon's PowerPoint presentations should be available soon. Currently The SPC Blog has versions that can neither be copied nor legibly uploaded. Please be patient!

We also have a question, which readers are invited to answer.  Lisa Page asks: 

"In Dr Cullen's presentation he mentioned the possibility that an applicant could benefit from both an six month extension to an SPC under the paediatric regulation and a one year extension to a marketing authorisation for a new clinical indication? In what circumstances can the SPC Blog readers see that this would be a practical benefit to an applicant bearing in mind that they could have selected a one year extension to marketing authorisation under the paediatric regulation in the first instance?"

If you have any bright ideas, please post them as Comments below or email them here